FDA issued draft guidance, which, if implemented, would remove requirement for a switching study for demonstrating biosimilar interchangeability. Citing research showing no additional safety concerns if pts switched from reference biologics to biosimilars https://t.co/MBvI4yxajW https://t.co/sEE654E2rl
Links:
FDA Issues Draft Guidance on Demonstrating Biosimilar Interchangeability
https://buff.ly/4dtDjgO
Aug-06-2024


